Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K834039 |
Device Name |
INFANT VENT CATHETER 12001 W/SIDE VENT |
Applicant |
DLP, INC. |
P.O.BOX 409 |
620 WATSONS S.W. |
GRAND RAPIDS,
MI
49501
|
|
Correspondent |
DLP, INC. |
P.O.BOX 409 |
620 WATSONS S.W. |
GRAND RAPIDS,
MI
49501
|
|
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 11/23/1983 |
Decision Date | 01/03/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|